Stanley Feld M.D.,FACP,MACE
It is obvious to me that Obamacare is going to rely on expert panels of the government’s choosing to determine if there is enough evidence for physicians to perform certain tests, prescribe certain medication or perform certain surgeries.
The panel evaluates the quality of data in published studies. The “medical experts” are not experts in the field of medicine they are evaluating.
Many of these studies do not take into account the natural history of a disease or the common sense use of clinical judgment.
The panels’ conclusions are used by CMS to determine reimbursements for tests, medications and procedures.
The most recent publicized examples have resulted in controversies between the US Preventative Services Task Force (USPSTF) experts and expert specialists in each medical field. The examples include mammogram testing, PSA testing and bone density testing to name a few.
Medical care cannot be commoditized. The evidence of efficacy is always changing. Much of the clinical research is not completely vigorous. It cannot be put into a nice computer evaluation box.
Published studies are restrictive. It is very difficult to define best practices using evidence based medical care. Many studies are poorly designed. Most clinical studies do not include long term follow up.
Most clinical insights into the natural history of disease are the result observational data. Observational data is not given as much credit as double blind placebo controlled longitudinal studies in evaluating strength of data.
Double blind longitudinal studies are becoming rare because they are too expensive to design and take too long to determine if they alter the course of the disease.
Nevertheless the expert panels to be used in Obamacare are set up to determine payment policy. These payment determinations have many deficiencies.
The error in determining payment policy can lead to restriction of access to care. These errors can also lead to the onset of chronic disease complications. Chronic disease complications can lead to an increase of medical care costs.
One such abuse is the USPSTF refusing to endorse widespread screening for vitamin D levels in healthy adults, despite research suggesting that a majority of Americans may be deficient or insufficient in vitamin D.
“The United States Preventive Services Task Force decided not to recommend routine testing for vitamin D levels in part because it was not clear whether otherwise healthy adults with low levels would actually benefit from taking supplements of the vitamin.”
The panel members concluded that there was not enough evidence to either endorse or advise against regular vitamin D screening in most adults.
The panel members suggested that testing is something that should be considered case by case.
People produce normal vitamin D levels in their blood when exposed to sun for at least 10 minutes a day. Most Americans avoid sun exposure because of fear of skin cancer and skin aging. Sun block is used to avoid UV light that stimulates the production of normal vitamin D levels.
Is the government going to reimburse physicians for using their judgment in testing for serum vitamin D levels? I doubt it.
The panel hedged. “This is not a recommendation for or against it,” said Dr. Douglas K. Owens, a panel member and director of the Center for Primary Care and Outcomes Research at Stanford medical school. “In our view, when people have concerns or questions about vitamin D, they should discuss them with their clinicians.”
In my view the panel knows very little about vitamin D deficiency. Some studies estimate that more than two-thirds of Americans have deficient or insufficient vitamin D levels.
The first symptom in vitamin D deficiency/insufficiency is weakness in large muscles bundles. An easy clinical test is to see if a patient can rise from a sitting position without leaning on his/her elbow or a support. If a patient needs support it is likely that he has a vitamin D deficiency.
The USPSTF panel issued a draft recommendation based on a review of evidence from more than a dozen studies that evaluated the effects of vitamin D treatment in generally healthy adults.
The studies used vitamin D3 doses ranging from 400 to 4,800 international units (I.U.) daily, and the studies were from two months to seven years duration.
400 I.U. per day is insufficient replacement therapy. 400 I.U. per day would have no impact on inhibiting a disease process or preventing a disease from occurring. It would provide no insight into helping prevent chronic diseases implicated in vitamin D deficiency.
Clinical studies lasting two months would not provide any insight into the efficacy of replacement therapy in chronic diseases such as osteoporosis, hypertension, heart disease, inflammatory bowel syndrome or cancer, to name a few.
Vitamin D deficiency has the greatest direct impact is on the development of osteoporosis. Most of the osteoporosis research has been focused on preventing fractures after a vertebral fracture has occurred.
Most patients with osteoporosis have a component of osteomalacia. Osteomalacia is a thinning of the bone secondary to a vitamin D insufficiency and a decrease in calcium absorption from the gut.
Osteoporosis takes 30 years to result in bone fractures. Meanwhile patients with osteoporosis also have had a vitamin D deficiency.
A double blind placebo controlled study for osteoporosis would be impossible to conduct or fund.
In recent years observation data has shown that patients with vitamin D insufficiency or deficiency have an increased incidence of several cancers, hypertension, heart disease (probably as a result of hypertension) and irritable bowel syndrome. This is all observational data that has been discounted by the USPSTF.
The natural history of many cancers is unknown. There are many confounding variables to cancer. However, the observed relationship to vitamin D deficiency or insufficiency is strong and should be heeded by the government.
The design of generating these Task Force Guidelines is defective.
When and if Obamacare takes over the total healthcare system as the single party payer, Americans will experience a restriction to access of care that might result in an increase in the complications of many chronic diseases.
It is too late to test a vitamin D level once the symptoms are presented.
It will have no impact on inhibiting a disease process or preventing a disease from occurring.
This onset of the chronic disease will result in higher costs to the healthcare system.
The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone.
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